Online Education Module (ESTIMATE: Estimating Polyp Size With Snare Tool to Improve Measurement Accuracy for Trainee Education) to Accurately Classify Polyp Size
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test.
研究概览
简要总结
Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).
详细描述
Study Design This is a prospective, multicenter educational randomized controlled trial. Trainees from five Accreditation Council for Graduate Medical Education (ACGME)-accredited GI fellowship training programs in the US will be invited to participate.
Study Materials (ESTIMATE Online Educational Module) The Estimating Polyp Size with Snare Tool to Improve Measurement Accuracy for Trainee Education (ESTIMATE) online educational module was developed by the study team over an 11-month development phase from September 2020 - August 2021. ESTIMATE is a user-friendly, interactive, web-based teaching module consisting of two main educational components: (1) video instruction and (2) real-time feedback during a polyp size assessment test. Video instruction is provided in a five-minute didactic clip that narrates the importance of accurate polyp size classification and demonstrates proper technique for positioning the snare to estimate polyp size. Examples of both correct and incorrect technique are provided. Several case examples, with opportunity for trainee interaction and response, are also included.
The polyp size assessment test includes 40 polyp sizing questions. Each question contains a still image of a polyp with an adjacent snare and asks participants to correctly identify the polyp's size into one of the following clinically relevant size categories: diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm), as well as the exact polyp size in mm. Participants are also asked to provide their confidence level (high or low) with each response. High confidence is defined as a sufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response. Low confidence is defined as an insufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response.
Real-time feedback on correct polyp size is provided immediately after a response is submitted in the form of a series of images with overlying graphics that demonstrate polyp size relative to the adjacent snare with a final image of the resected polyp affixed to a cork board and ruler. Investigators used measurement of the immediate post-resection, pre-formalin fixation polyp affixed to a cork board with an adjacent ruler to determine correct size. The feedback image deck will be provided in continuous fashion after each response as participants progress through the test.
Randomization In order to assess the impact of the key educational components of our module (video instruction and feedback), participants will be randomized in REDCap to one of four study groups: control, video-only, feedback-only, or video + feedback. The control group will complete the 40-item polyp size assessment test without receiving any video instruction or feedback. The video-only group will watch the video instructional clip and then completed the assessment, but will not receive any feedback after each question. The feedback-only group will receive feedback after each question, but will not watch the video. Lastly, the video + feedback group will receive both video instruction and feedback as they complete the assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators will be blinded regarding which participants are randomized to which arm.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GI trainees who have never received formal training in, nor had participated in a research study on, polyp sizing
- •Informed consent
排除标准
- •Those who do not complete the educational module during the allotted time
研究组 & 干预措施
Control
No video tutorial, no feedback
Feedback
Feedback only
干预措施: ESTIMATE (Other)
Video
Video tutorial only
干预措施: ESTIMATE (Other)
Video + Feedback
VIdeo tutorial and feedback
干预措施: ESTIMATE (Other)
结局指标
主要结局
Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test.
时间窗: through study completion, estimated 1 year
The gold standard polyp size for the polyp images on the polyp sizing test was determined by affixing the polyp to a cork board post-procedure and measuring it with an adjacent ruler. The actual polyp size was determined by meauring it against the adjacent ruler. Polyps 1-5 mm were categorized as diminutive, polyps 6-9 mm were categorized as small and polyps ≥10 mm were categorized as large. Participants completed a 40 item polyp sizing test where participants designated the polyp as either dimunitive (1-5mm), small (6-9mm) or large (≥10mm). The primary outcome was the rate that each participant correctly designated polyp size categories based on the gold standard.
次要结局
- Participant report of categorical high versus low confidence on each response of the 40 item polyp sizing test(through study completion, estimated 1 year)
- Participant entered rate of accurate polyp size by millimeter on 40 question polyp sizing test.(through study completion, estimated 1 year)
- Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test(through study completion, estimated 1 year)
- Proportion of participant responses that underestimate actual polyp size category versus overestimate actual polyp size category on the 40-question polyp sizing test.(through study completion, estimated 1 year)